Specialist Clinical Supplies Quality Assurance

Vor 3 Tagen

Schachen LU, Luzern, Schweiz MSD Vollzeit

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Specialist Clinical Supplies Quality Assurance reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via related disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes direct support for batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions. Areas of focus of this position evolve around the detailed workings of clinical packaging, labelling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex and niche supply chains and supply types to support clinical protocols as well as Managed Access Programs, Joint Ventures, Collaborations, Independent Investigator-Initiated Studies.

Responsibilities:

  • Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies and procedures of our Company and compliance with all governing regulations
  • Coordinate and support the preparation of procedures, processes and quality improvements
  • Assists in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine and recovery actions
  • Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
  • Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations
  • Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times
  • Managing investigation, change request, risk assessments and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible
  • Actively using and championing the use of Lean Six Sigma and our Company's Production System tools, both in problem solving and day-to-day operational activities

Your Profile:

Education:

  • Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred

Required Experience and Skills:

  • Minimum of two years' experience in the pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations
  • Effectiveness and creativity in approaching and solving technical problems
  • In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area
  • Basic understanding in using Microsoft applications (such as Excel, Outlook, PowerPoint, Teams and/or Access)
  • Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as stakeholder management and conflict resolution skills
  • Demonstrated teamwork skills and ability to work independently
  • Attention to detail, flexibility and an awareness of production and quality control problems

Preferred Skills:

  • Familiarity with batch disposition (release) activities is strongly preferred and prior batch disposition experience is a plus
  • Prior experience reviewing and approving investigations, deviation management and Corrective and Preventive Actions (CAPAs)
  • Previous background in quality control, quality assurance, auditing or regulatory affairs
  • Ability to independently manage multiple priorities and projects
  • Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives
  • Demonstrated analytical and problem-solving skills, knowledge of Lean Six Sigma and Project Management
  • Computer skills; knowledge and competency in Enterprise Resource Planning and Deviation Management (SAP), VeevaVault and TrackWise

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/29/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/29/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R297194

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